DEVICE: AVENIO Millisect Tip Small (07613336146583)

Device Identifier (DI) Information

AVENIO Millisect Tip Small
08106509001
In Commercial Distribution
08106509001
Roche Molecular Systems, Inc.
07613336146583
GS1

1
071674100 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62867 Slide-mounted-tissue dissection system excision tip IVD
A small cutting instrument designed to be mounted on the robotic arm of a digital-image-guided dissection system to excise its microscope-slide-mounted tissue specimens. It is a precision cutting mill bit which is also capable of dispensing dissecting buffer solution and aspirating the excised specimens. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

82bb1f3f-77dc-4098-a539-d4cd2d85d6e4
May 08, 2020
1
April 30, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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